Scientists Push for More Leeway To Enroll Subjects in Experiments

By Charles Ornstein and Rebecca Trounson
LOS ANGELES TIMES
-- The University of California and several health groups are lobbying the state Legislature for more leeway to enroll incapacitated patients in research studies.

But patient activists say the UC system doesn’t deserve this new authority because of its previous lapses in protecting human research subjects in medical experiments. And bioethicists worry that the proposed legislation could place patients at risk for exploitation.

The California bill, which passed the Assembly and is headed for a Senate vote as early as Wednesday, would specifically allow certain relatives, from spouses to the closest available family member, to approve studies involving patients unable to give consent themselves. Such patients might include victims of strokes or Alzheimer’s disease, for example, or those in comas.

The university, along with such groups as the American Heart Association and California chapters of the Alzheimer’s Association, say they need more flexibility to advance treatment of life-threatening diseases and injuries.

The bill’s advocates also say they need greater clarity: The consent laws on the books are open to interpretation.

Federal law allows any “legally appointed representative” to give consent on behalf of an incapacitated patient, leaving interpretation of that term up to individual states. California law is more restrictive, giving authority only to those appointed by the courts or legally approved by the patients before incapacitation. The state’s definition may or may not include close relatives.

The situation is “a bit of a mess,” said Regis Kelly, executive vice chancellor of UC San Francisco.

In the meantime, individual UC campuses and other research institutions are interpreting the laws in various ways. In April, on the advice of attorneys, UCLA issued a moratorium preventing researchers from enrolling patients in studies if they are unable to give consent. But other UC campuses continue to allow such research if a family member consents.

Questions over the precise meaning of the law come as research institutions around the country have come under fire in recent years for controversial studies, some of which have led to patient deaths.

The California bill would create a list of relatives who could give consent for a patient who is incapacitated.

Some patient advocates are suspicious. “This is like a grab for more power” by UC, said Vera Hassner Sharav, president of the Alliance for Human Research Protection. “In fact, they haven’t earned it at all. They haven’t complied with the existing regulations and law.”

Since June 2001, the U.S. Office of Human Research Protections has criticized three UC campuses -- UCLA, UC Irvine and UC San Francisco -- for more minor instances of failing to inform subjects of the risks they faced in experiments.

UC officials say they have made every attempt to rectify past problems, and the federal office has expressed satisfaction with each campus’ efforts.

“If you go back a few years anywhere in the country, it (the protections) would not meet the standards of today,” said William Parker, vice chancellor for research at UC Irvine. “We’ve made improvements since then.”

The American Stroke Association is a strong advocate of the bill, saying the ability to get patients the most up-to-date treatment is urgently needed.

“When a patient presents at the emergency room, the most appropriate treatment for that patient is often still in an experimental state,” said Marc Burgat, a legislative advocate for the stroke association in the state capital, Sacramento. “We would like to have the law very specifically clarified.”

Bioethicists say it’s premature to change the California law. So far, they say, studies have shown that family members and doctors are poor predictors of what treatments patients actually want.

“What gives me pause is that there has not been any real public discussion of whether this is something that society wants to sanction or not,” said Jonathan Moreno, director of the Center for Biomedical Ethics at the University of Virginia Medical School.

Bioethicists note that UC is not the only university system to come under criticism for its research protections. Alleging serious violations, the federal government in the past three years temporarily suspended all research involving humans at several schools, including Duke University and Johns Hopkins.

“Some of the most advanced research centers seem to have the worst problems, probably because they have some of the most aggressive researchers going after diseases,” said Alexander Capron, a bioethicist at the University of Southern California.